Table 2.
Clinical trials stimulating innate immunity against bone and soft tissue sarcomas.
| Agent | Number of patients | Diagnosis | Treatment | Follow-up | Clinical result |
|---|---|---|---|---|---|
| IL-2 [16] | 6 | Osteosarcoma, Ewing's sarcoma |
6–12 × 106 IU/m2
for 5 days by every 3 weeks |
7–71 months | Complete response (CR): 5 Progressive disease (PD): 5 |
| IFNs [17] | 3 | Osteosarcoma | 2.5–5 × 106 IU/mL twice or thrice weekly |
6–8 months | CR: 2 PD: 1 |
| IFN-α2 [18] | 20 | Osteosarcoma, fibrosarcoma, chondrosarcoma, and malignant fibrous histiocytoma |
5 × 107 IU/m2
thrice weekly |
1–3 months | Partial response (PR): 3 |
| IFN-α [19] | 89 | Osteosarcoma | Cohort 1 (70 patients); 3 × 106 IU daily for a month Cohort 2 (19 patients); 3 × 106 IU daily for 3–5 years |
10 years | Metastatic free survival: 39% Sarcoma specific survival: 43% |
| IFN-β [20] | 158 | Osteosarcoma (COSS-80) |
1 × 105 IU/kg for 22 weeks | 30 months | Disease-free survival +IFN: 77% −IFN: 73% (N.S.) |
| Pegylated IFN-α2b [21] | 715 | Osteosarcoma (EURAMOS-1) |
Methotrexate, adriamycin, and cisplatin (MAP) +/−IFN (0.5–1.0 μg/kg/wk) for 2 years |
Median follow-up 3.1 years |
Event-free survival +IFN: 77% −IFN: 74% (N.S.) |
| L-MTP-PE [22] | 662 | Osteosarcoma (INT 0133) |
MAP alone, MAP + L-MTP-PE, MAP + ifosfamide, MAP + ifosfamide + L-MTP-PE |
6 years | Overall survival +L-MTP-PE: 78% −L-MTP-PE: 70% Event free survival No significant difference |